Severe adverse events (SAEs) monitoring and documentation is the responsibility of many key individuals in the clinical research study. Reconciling SAEs involves documenting those adverse events on the CRFs, as well as following up on them. To this end, both the clinical study coordinator and CRA play a central role in documenting those events. Here's how.
The Coordinator’s Role in SAEs Reconciliation
As soon as they become available, the study coordinator or study nurse will accurately record those events in the SAE report section of the case report form. The principal investigator will determine whether or not the events observed are related to the investigational drug (s). Those SAEs will be communicated to the sponsor, which in turn will notify the applicable regulatory authorities.
The CRA’s Role in SAE Reconciliation
The best way the monitor can reconcile SAEs is through conducting periodic monitoring visits. If SAEs are properly monitored at every single visit, SAE reconciliation should not be too cumbersome at the end. The CRA will evaluate the CRFs and determine whether SAEs were documented properly and followed up. Were those SAEs filed on time? Are there proper follow-up on those SAEs? Was the sponsor notified of the events in a timely manner? Download "Sample SAEs Report Reconciliation Checklist". Please share your thoughts below or share on your favorite social media website.
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